The following data is part of a premarket notification filed by Ranfac Corp. with the FDA for Needle, Pneumoperitoneum, Spring Loaded.
| Device ID | K930474 |
| 510k Number | K930474 |
| Device Name: | NEEDLE, PNEUMOPERITONEUM, SPRING LOADED |
| Classification | Pneumoperitoneum Needle |
| Applicant | RANFAC CORP. 30 DOHERTY AVE., P.O. BOX 635 AVON INDUSTRIAL PARK Avon, MA 02322 |
| Contact | John P Sbardelli |
| Correspondent | John P Sbardelli RANFAC CORP. 30 DOHERTY AVE., P.O. BOX 635 AVON INDUSTRIAL PARK Avon, MA 02322 |
| Product Code | FHO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-28 |
| Decision Date | 1993-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20858690006994 | K930474 | 000 |
| 20858690006208 | K930474 | 000 |